HangoverNCT01400204
Naturalistic Study Into the Hangover Effects of MDMA
An observational study of Hangover, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial summary
The aim of the study is to compare hangover effects of MDMA users versus those who used other drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day participants complete a questionnaire about the presence and severity of potential hangover symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hangover
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recreational poly-drug users who were guests at a privat New Years Eve party
Who may be able to join
- poly drug user
- 18+ years old
Who cannot join
- mental or physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Naturalistic Study Comparing the Hangover Effects of MDMA, Other Drugs, and Alcohol in a Sample of Recreational Polydrug Users
The aim of the study is to compare hangover effects of MDMA users versus those who used other drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day participants complete a questionnaire about the presence and severity of potential hangover symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4 weeks, after a drug-free week, the BSI is completed again to serve as a reference.
Read the detailed description
A convenience sample was invited by e-mail to participate in the study, via the organizer of a private New Years Party.It was attempted to include as much participants as possible. Hence, no sampling method was applied when recruiting participants.
- Conditions
- Hangover
- Keywords
- hangover, next day effects, MDMA, Alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MDMA | poly drug users that used MDMA at New Years Eve | |
| Other Drugs | poly drug users that used drugs at New Years Eve, but not MDMA | |
| Alcohol | poly drug users that used no drugs at New Years Eve, but did consume alcohol |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HangoverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Joris C Verster, PhD, Principal investigator, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400204
- Sponsor's protocol ID
- ppo-010-212
- Status last verified
- Jul 2011
- First submitted
- 21 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Study Comparing the Hangover Effects of MDMA, Other Drugs, and Alcohol in a Sample of Recreational Polydrug Users
- ClinicalTrials.gov ID
- NCT01400204
- Acronym / sponsor ID
- ppo-010-212
- Conditions
- Hangover
- Keywords
- hangover, next day effects, MDMA, Alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare hangover effects of MDMA users versus those who used other drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day participants complete a questionnaire about the presence and severity of potential hangover symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4 weeks, after a drug-free week, the BSI is completed again to serve as a reference.
Detailed description
A convenience sample was invited by e-mail to participate in the study, via the organizer of a private New Years Party.It was attempted to include as much participants as possible. Hence, no sampling method was applied when recruiting participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDMA | – | –poly drug users that used MDMA at New Years Eve |
| Other Drugs | – | –poly drug users that used drugs at New Years Eve, but not MDMA |
| Alcohol | – | –poly drug users that used no drugs at New Years Eve, but did consume alcohol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recreational poly-drug users who were guests at a privat New Years Eve party
Key inclusion criteria (2 listed)
- poly drug user
- 18+ years old
Key exclusion criteria (1 listed)
- mental or physical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris C Verster, PhD principal investigator
Utrecht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hangover, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.